# K010817: MX8000 V5.0 CT System

- Pathway: 510(k) (Traditional)
- Applicant: Philips Medical Systems (Cleveland), Inc.
- Decided: Jun 15, 2001 after 88 days
- Product code: JAK (System, X-Ray, Tomography, Computed)
- Device class: 2
- Regulation: 21 CFR 892.1750
- Recalls of this device: 12 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
264 later devices descend from it; 3 cite it directly.
0 of 265 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K012009: MX8000 Idt CT System (2001), 263 descendants of its own
- K033326: Philips Plus Computed Tomography System (2003), 214 descendants of its own
- K042293: Brilliance CT, Private Practice CV Configuration, CT Scanner (2004), 147 descendants of its own
- K130159: Qlab Quantification Software Heart Model (2013), 92 descendants of its own
- K132165: Qlab Quantification Software (2013), 91 descendants of its own

## Recalls of this device
- May 1, 2021 · Class II · Z-1979-2021: Significant wear of the Monitor Bracket Assembly shaft goes unrecognized could potentially lead to the Monitor Bracket Assembly detaching from the Suspension Arm and result in potential hazard for the
- Mar 16, 2015 · Class II · Z-1647-2015: The firm was informed that while raising the patient couch on the system to perform an exam, the couch unexpectedly descended to the lowest point without being commanded to do so.
- Apr 1, 2014 · Class II · Z-1722-2014: A customer reported that the table top had become free floating. A Field Service Engineer (FSE) confirmed that the service latch had become disengaged.
- Dec 20, 2012 · Class II · Z-0945-2013: Philips Healthcare received reports from the field stating the patient table on a system had an unexpected downward movement while a patient was on the table. Philips has determined the cause was a ma
- Jun 3, 2011 · Not classified · Z-2914-2011: Philips Medical Systems decided to conduct a recall/field correction of the patient support vertical brake hub component in all of their CT MX8000 Dual v. Exp Computed Tomography X-Ray System scanners
- Sep 23, 2008 · Not classified · Z-0597-2009: The product is being recalled because the patient support may travel downwards without being commanded to move.
- Nov 6, 2006 · Not classified · Z-0014-2007: A potential anomaly was identified on the CT subsytem, which could result in the radiation dose being different than the calculated dose reported to the operator.
- Dec 27, 2005 · Class II · Z-2709-2014: The system has a gap that can appear between the upper and lower tilt stand covers. The fingers may be squeezed if a person was to place them in this region while the gantry was tilting from an angle 
- Mar 11, 2005 · Not classified · Z-1414-05: When two product applications called Flip and Secondary Capture are used together, it is possible for image orientation labels to be incorrect.
- Mar 11, 2005 · Not classified · Z-1410-05: When two product applications called Flip and Secondary Capture are used together, it is possible for image orientation labels to be incorrect.
- Mar 11, 2005 · Not classified · Z-1412-05: When two product applications called Flip and Secondary Capture are used together, it is possible for image orientation labels to be incorrect.
- Apr 2, 2003 · Not classified · Z-0836-03: Patient images may be incorrectly stored in the archive directory of a different patient.

Source page: https://510kreport.com/device/K010817
Methodology: https://510kreport.com/methodology